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Corticotropin injection gel: Pediatric drug information

Corticotropin injection gel: Pediatric drug information
(For additional information see "Corticotropin injection gel: Drug information" and see "Corticotropin injection gel: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Acthar;
  • Cortrophin
Brand Names: Canada
  • ACTH 40 [DSC]
Therapeutic Category
  • Adrenal Corticosteroid;
  • Infantile Spasms, Treatment
Dosing: Pediatric

Note: Sudden withdrawal may lead to adrenal insufficiency or recurrent symptoms; tapering the dose prior to discontinuation of therapy may be necessary following prolonged administration.

Infantile spasms

Infantile spasms:

Note: Expert consensus guidelines based on currently available evidence show that corticotropin (ACTH) appears to be more effective than oral corticosteroids or vigabatrin (monotherapy) for the treatment of infantile spasms in most patients and is used most frequently for initial management of infantile spasms. For patients with tuberous sclerosis complex, corticotropin may be used for non-responders to vigabatrin therapy (AAN [Go 2012]; ILAE [Wilmshurst 2015]; Knupp 2016).

Although various dosing regimens (primarily high-dose and moderate/low-dose) have been described in the literature, an optimal dosing regimen has not been defined (AAN [Go 2012]; Hancock 2013; Pellock 2010; Mackay 2004). With the high-dose regimen, initial efficacy response rates of 86% to 93% during the respective study periods have been reported (Baram 1996; Snead 1989); however, a randomized, comparative trial did not show the high-dose superior to low-dose ACTH; however, hypertension occurred more frequently in the high-dose group (Hrachovy 1994). Guidelines suggest consideration for low-dose ACTH regimens (as an alternative to high-dose); however, literature also suggests that the two dosing regimens are probably equally effective for short-term treatment (AAN [Go 2012]). A US consensus report recommends short duration of high-dose (~2 weeks), followed by a taper (Pellock 2010). In clinical practice, high-dose ACTH is used more often by neurologists than low-dose protocols (Mytinger 2012). In the US market, Acthar gel has FDA approval for treatment of infantile spasm in patients <2 years of age; however, trials may have been conducted with other corticotropin repository gel products in other countries.

Infants and Children <2 years:

High dose: Body-surface area (BSA) directed dosing: IM: 75 units/m2/dose twice daily or 150 units/m2/dose once daily for 2 weeks, followed by a 2-week taper: 30 units/m2/dose once daily in the morning for 3 days, followed by 15 units/m2/dose once daily in the morning for 3 days, followed by 10 units/m2/dose once daily in the morning for 3 days and 10 units/m2/dose every other morning for 6 days (Hodgeman 2016; Acthar manufacturer's labeling). In practice, some centers have used maximum doses of 80 units/dose twice daily or 160 units/dose once daily based on currently available dosage forms.

Low dose: Fixed dosing: IM: Initial: 20 units/day for 2 weeks; if patient responds, taper and discontinue over a 1-week period; if patient does not respond, increase dose to 30 units/day for 4 weeks then taper and discontinue over a 1-week period. Dosing based on a prospective, single-blind study which reported no major difference in effectiveness between high-dose long-duration versus low-dose short-duration ACTH therapy (Hrachovy 1994).

Anti-inflammatory or immunosuppressive

Anti-inflammatory or immunosuppressive:

Note: Although FDA approved, use has been replaced by other agents; most expert guidelines do not address corticotropin as a therapeutic option (ACR [Ringold 2013]; CAARA [Huber 2010]; KDIGO 2012):

Children >2 years and Adolescents:

Fixed dosing: Acthar: IM, SUBQ: 40 to 80 units/dose every 24 to 72 hours (manufacturer's labeling).

Weight-directed dosing: IM: 0.8 units/kg/day or 25 units/m2/day divided every 12 to 24 hours (Gal 2007).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; use with caution in cirrhosis.

Dosing: Adult

(For additional information see "Corticotropin injection gel: Drug information")

Note: Indication-specific dosing is not provided in the manufacturer's labeling for most labeled uses. Individualize dosage and frequency based on the severity of the disease and the initial response of the patient. Sudden withdrawal may lead to adrenal insufficiency or recurrent symptoms; tapering the dose and increasing the injection interval prior to discontinuation may be necessary following prolonged administration.

Usual dosage range :

Note: Generally used as an adjunctive agent in patients whose disease is refractory to conventional treatments. Because maximal adrenal stimulation may not occur in the first few days of treatment, other therapies should be initiated when an immediate effect is needed.

IM, SUBQ: 40 to 80 units every 24 to 72 hours.

Indication-specific dosing:

Multiple sclerosis, acute exacerbation

Multiple sclerosis, acute exacerbation (alternative therapy):

Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014). Corticotropin may be an alternative therapy if IV corticosteroids cannot be administered or are not tolerated (Simsarian 2011).

IM, SUBQ: 80 to 120 units/day for 2 to 3 weeks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling; use with caution in cirrhosis.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for infants and children for infantile spasms unless otherwise noted. Other adverse events associated with corticosteroids may also occur.

>10%:

Cardiovascular: Hypertension (11%)

Infection: Infection (20%)

Nervous system: Seizure (12%)

1% to 10%:

Cardiovascular: Cardiac abnormality (cardiac hypertrophy: 3%)

Endocrine & metabolic: Drug-induced Cushing's syndrome (3%), weight gain (1%)

Gastrointestinal: Decreased appetite (3%), diarrhea (3%), vomiting (3%)

Infection: Candidiasis (≥2%)

Nervous system: Irritability (7%)

Otic: Otitis media (≥2%)

Respiratory: Nasal congestion (1%), pneumonia (≥2%), upper respiratory tract infection (≥2%)

Miscellaneous: Fever (5%)

Frequency not defined (all indications and populations):

Dermatologic: Acne vulgaris, ecchymoses, hyperpigmentation, inadvertent suppression of skin test reaction

Endocrine & metabolic: Decreased serum calcium, decreased serum potassium, growth retardation, impaired glucose tolerance/prediabetes, negative nitrogen balance, pituitary insufficiency, secondary adrenocortical insufficiency, sodium retention

Gastrointestinal: Acute peptic ulcer with hemorrhage and perforation

Hematologic & oncologic: Petechia

Immunologic: Antibody development

Nervous system: Idiopathic intracranial hypertension

Neuromuscular & skeletal: Amyotrophy, aseptic necrosis of femoral head, aseptic necrosis of humeral head, osteoporosis, pathological fracture (long bones), steroid myopathy

Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, subcapsular posterior cataract

Miscellaneous: Wound healing impairment

Postmarketing (all indications and populations):

Cardiovascular: Atrial fibrillation, heart failure, necrotizing angiitis, palpitations, shock, subdural hematoma

Dermatologic: Diaphoresis, epidermal thinning, facial erythema

Endocrine & metabolic: Fluid retention (including peripheral swelling), hirsutism, hypokalemic alkalosis, increased serum glucose, menstrual disease

Gastrointestinal: Abdominal distention, impaired intestinal carbohydrate absorption, nausea, pancreatitis, ulcerative esophagitis

Hypersensitivity: Anaphylactic shock, anaphylaxis, hypersensitivity reaction

Infection: Abscess

Local: Injection site reaction

Nervous stem: Dizziness, fatigue, headache, insomnia, intracranial hemorrhage, lethargy, malaise, myasthenia, reversible cerebral atrophy (usually secondary to hypertension), vertigo

Neuromuscular & skeletal: Asthenia, vertebral compression fracture

Contraindications

Hypersensitivity to proteins of porcine origin; patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, peptic ulcer disease, recent surgery, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction; IV administration.

Acthar gel: Additional contraindications: Children <2 years of age with suspected congenital infections; coadministration of live or live attenuated vaccines.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Symptoms of adrenal insufficiency may be difficult to detect in infants treated for infantile spasms.

• Electrolyte disturbances: May increase retention of sodium and wasting of calcium and potassium; sodium restriction and/or potassium supplementation may be required.

• Hypersensitivity reactions: Antibodies may develop following prolonged use and increase the risk of hypersensitivity reactions.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Close observation is required in patients with tuberculosis (TB) infection (latent TB) and/or TB reactivity; if therapy is prolonged, prophylaxis should be started.

• Psychiatric disturbances: Corticosteroids may cause psychiatric disturbances, including depression, euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and psychotic manifestations; effects are reversible upon discontinuation of therapy. Preexisting psychiatric conditions (eg, emotional instability, psychotic tendencies) may be exacerbated by corticosteroid use.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with hypertension; use has been associated with fluid retention and hypertension.

• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI disease (eg, diverticulitis, ulcerative colitis, risk of impending perforation, fresh intestinal anastomoses) or abscess/pyogenic infections due to risk of gastric ulcer, GI perforation, and GI bleeding.

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred, especially during initial treatment with corticosteroids.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged corticosteroid use.

• Osteoporosis: Use with caution in patients of any age at risk for osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in patients with hyperthyroidism and decreases in patients with hypothyroidism.

Special populations:

• Pediatric: May affect growth velocity.

Concurrent drug therapy issues:

• Vaccines: For Acthar gel, concomitant use of live or live attenuated vaccines is contraindicated; use caution with inactivated vaccines (response may be variable). For Purified Cortrophin gel, avoid vaccination against smallpox; use caution with other immunization procedures.

Other warnings/precautions:

• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.

Warnings: Additional Pediatric Considerations

Use with caution in patients with osteoporosis; underlying clinical condition may also impact bone health and osteoporotic effect of corticosteroids and corticotropin in pediatric patients (Leonard 2007). Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, personality changes, and irritability (especially in infants).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, Injection:

Acthar: 80 units/mL (5 mL) [contains phenol]

Cortrophin: 80 units/mL (1 mL, 5 mL) [contains phenol]

Generic Equivalent Available: US

No

Pricing: US

Gel (Acthar Injection)

80 units/mL (per mL): $10,248.72

Gel (Cortrophin Injection)

80 units/mL (per mL): $8,394.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Injection:

ACTH 40: 40 units ([DSC])

Prescribing and Access Restrictions

Acthar Gel is only available through specialty pharmacy distribution and not through traditional distribution sources (eg, wholesalers, retail pharmacies). Hospitals wishing to acquire Acthar Gel should contact FFF Enterprises (1-800-843-7477).

After treatment is initiated, discharge or outpatient prescriptions should be submitted to the Acthar Support and Access Program (A.S.A.P.) in order to ensure an uninterrupted supply of the medication. The Acthar Referral/Prescription form is available online at https://actharhcp.com/acthar-patient-support/supporting-patients-and-practices/#patient-support-tabs.

Additional information is available for the A.S.A.P. at https://actharhcp.com/acthar-patient-support/access-support/.

Administration: Pediatric

Parenteral: Warm gel before administration; do not over-pressurize vial when withdrawing product. May be administered IM or SubQ; IM route is recommended for the treatment of infantile spasms; do not administer IV.

Administration: Adult

IM, SUBQ: For IM or SUBQ use; do not administer IV. Warm gel to room temperature before administration. Do not over-pressurize vial prior to withdrawing product.

Storage/Stability

Store in the refrigerator at 2°C to 8°C (36°F to 46°F).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s068lbl.pdf#page=18, must be dispensed with this medication.

Use

Treatment of infantile spasms as monotherapy (Acthar: FDA approved in ages <2 years); adjunctive therapy for exacerbations/acute episodes of rheumatic disorders (eg, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis) (Acthar: FDA approved in ages >2 years and adults; Cortrophin: FDA approved in adults); exacerbations or maintenance therapy for collagen diseases (eg, systemic lupus erythematosus, systemic dermatomyositis) (Acthar: FDA approved in ages >2 years and adults; Cortrophin: FDA approved in adults); treatment of dermatologic (eg, severe erythema multiforme, Stevens-Johnson syndrome) and allergic (eg, serum sickness) states (Acthar: FDA approved in ages >2 years and adults; Cortrophin: FDA approved in adults); treatment of severe acute/chronic allergic and inflammatory ophthalmic disease (eg, keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation) and symptomatic sarcoidosis (Acthar: FDA approved in ages >2 years and adults; Cortrophin: FDA approved in adults); induction of diuresis or remission of proteinuria in patients with nephrotic syndrome without idiopathic uremia or due to lupus erythematosus (Acthar: FDA approved in ages >2 years and adults; Cortrophin: FDA approved in adults); treatment of acute exacerbations of multiple sclerosis (Acthar, Cortrophin: FDA approved in adults).

Medication Safety Issues
Sound-alike/look-alike issues:

Corticotropin may be confused with corticorelin, cosyntropin

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Abrocitinib. Management: The use of abrocitinib in combination with other immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy

Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Risk C: Monitor therapy

Androgens: Hypertension-Associated Agents may enhance the hypertensive effect of Androgens. Risk C: Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Antithymocyte Globulin (Equine): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of systemic corticosteroid is reduced. Corticosteroids (Systemic) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Baricitinib. Management: The use of baricitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification

BCG Products: Corticosteroids (Systemic) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Brincidofovir: Corticosteroids (Systemic) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk X: Avoid combination

Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Risk C: Monitor therapy

CAR-T Cell Immunotherapy: Corticosteroids (Systemic) may enhance the adverse/toxic effect of CAR-T Cell Immunotherapy. Specifically, the severity and duration of neurologic toxicities may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of CAR-T Cell Immunotherapy. Management: Avoid use of corticosteroids as premedication before treatment with CAR-T cell immunotherapy agents. Corticosteroids are indicated and may be required for treatment of toxicities such as cytokine release syndrome or neurologic toxicity. Risk D: Consider therapy modification

Cladribine: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Coccidioides immitis Skin Test: Corticosteroids (Systemic) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing systemic corticosteroids (dosed at 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks) several weeks prior to coccidioides immitis skin antigen testing. Risk D: Consider therapy modification

Corticorelin: Corticosteroids (Systemic) may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

Cosyntropin: Corticosteroids (Systemic) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

COVID-19 Vaccine (Adenovirus Vector): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters) Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Dengue Tetravalent Vaccine (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and systemic corticosteroids. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider therapy modification

Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

Deucravacitinib: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Management: The use of deucravacitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Filgotinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Filgotinib. Management: Coadministration of filgotinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider therapy modification

Gallium Ga 68 Dotatate: Corticosteroids (Systemic) may diminish the diagnostic effect of Gallium Ga 68 Dotatate. Risk C: Monitor therapy

Growth Hormone Analogs: Corticosteroids (Systemic) may diminish the therapeutic effect of Growth Hormone Analogs. Growth Hormone Analogs may decrease serum concentrations of the active metabolite(s) of Corticosteroids (Systemic). Risk C: Monitor therapy

Hyaluronidase: Corticosteroids (Systemic) may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Corticosteroids (Systemic) may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Management: Carefully consider the need for corticosteroids, at doses of a prednisone-equivalent of 10 mg or more per day, during the initiation of immune checkpoint inhibitor therapy. Use of corticosteroids to treat immune related adverse events is still recommended Risk D: Consider therapy modification

Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination

Inebilizumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Corticosteroids (Systemic) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiation of systemic corticosteroids at immunosuppressive doses. Influenza vaccines administered less than 14 days prior to or during such therapy should be repeated 3 months after therapy. Risk D: Consider therapy modification

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Risk C: Monitor therapy

Leflunomide: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as systemic corticosteroids. Risk D: Consider therapy modification

Licorice: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Lutetium Lu 177 Dotatate: Corticosteroids (Systemic) may diminish the therapeutic effect of Lutetium Lu 177 Dotatate. Management: Avoid repeated use of high-doses of corticosteroids during treatment with lutetium Lu 177 dotatate. Use of corticosteroids is still permitted for the treatment of neuroendocrine hormonal crisis. The effects of lower corticosteroid doses is unknown. Risk D: Consider therapy modification

Macimorelin: Corticosteroids (Systemic) may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

MetyraPONE: Corticosteroids (Systemic) may diminish the diagnostic effect of MetyraPONE. Management: Consider alternatives to the use of the metyrapone test in patients taking systemic corticosteroids. Risk D: Consider therapy modification

Mifamurtide: Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide. Risk X: Avoid combination

MiFEPRIStone: May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (eg, for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Risk X: Avoid combination

Mumps- Rubella- or Varicella-Containing Live Vaccines: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Management: If concomitant therapy is required, use the lowest dose for the shortest duration to limit the risk of myopathy or neuropathy. Monitor for new onset or worsening muscle weakness, reduction or loss of deep tendon reflexes, and peripheral sensory decriments Risk D: Consider therapy modification

Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Topical): May enhance the adverse/toxic effect of Corticosteroids (Systemic). Specifically, the risk of gastrointestinal bleeding, ulceration, and perforation may be increased. Risk C: Monitor therapy

Ocrelizumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Pidotimod: Corticosteroids (Systemic) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Risk X: Avoid combination

Pneumococcal Vaccines: Corticosteroids (Systemic) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Polymethylmethacrylate. Specifically, the risk for hypersensitivity or implant clearance may be increased. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Quinolones: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor therapy

Rabies Vaccine: Corticosteroids (Systemic) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ritodrine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Ritodrine. Risk C: Monitor therapy

Ruxolitinib (Topical): Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor therapy

Sargramostim: Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Risk C: Monitor therapy

Sipuleucel-T: Corticosteroids (Systemic) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing immunosuppressants, such as systemic corticosteroids, prior to initiating sipuleucel-T therapy. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone given for 2 or more weeks are immunosuppressive. Risk D: Consider therapy modification

Sodium Benzoate: Corticosteroids (Systemic) may diminish the therapeutic effect of Sodium Benzoate. Risk C: Monitor therapy

Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Risk C: Monitor therapy

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Risk C: Monitor therapy

Succinylcholine: Corticosteroids (Systemic) may enhance the neuromuscular-blocking effect of Succinylcholine. Risk C: Monitor therapy

Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Risk C: Monitor therapy

Tacrolimus (Topical): Corticosteroids (Systemic) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Corticosteroids (Systemic) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tofacitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification

Typhoid Vaccine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Upadacitinib. Management: Coadministration of upadacitinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider therapy modification

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Risk C: Monitor therapy

Vaccines (Inactivated/Non-Replicating): Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification

Vaccines (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines prior to therapy whenever possible. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Corticosteroids (Systemic) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Yellow Fever Vaccine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Dietary Considerations

May require increased dietary or supplemental intake of potassium; may require decreased dietary intake of sodium.

Pregnancy Considerations

Endogenous corticotropin concentrations are increased near delivery (Smith 2007).

Corticotropin stimulates an endogenous steroid response; outcomes observed following systemic corticosteroid use during pregnancy may be relevant. Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts; however, information is conflicting and may be influenced by maternal dose, duration/frequency of exposure, and indication for use. Additional data are needed to evaluate any potential risk of systemic corticosteroids and other adverse pregnancy outcomes (eg, gestational diabetes mellitus, low birth weight, preeclampsia, preterm birth) (ACOG 2019; Bandoli 2017; Lunghi 2010; Skuladottir 2014). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.

Monitoring Parameters

Blood pressure, serum glucose, potassium, and calcium and clinical presence of adverse effects. Monitor intraocular pressure (if therapy >6 weeks) for signs of secondary ocular infections; linear growth of pediatric patients (with chronic use), assess HPA suppression; for infantile spasms, monitor seizure frequency, type, and duration.

Mechanism of Action

Stimulates the adrenal cortex to secrete adrenal steroids (including cortisol), weakly androgenic substances, and aldosterone. Prolonged administration of large doses induces hyperplasia and hypertrophy of the adrenal cortex and continuous high output of cortisol, corticosterone, and weak androgens. Trophic effects on the adrenal cortex appear to be mediated by cyclic adenosine monophosphate. Also reported to bind to melanocortin receptors.

Pharmacokinetics (Adult Data Unless Noted)

Onset: Maximum effect: Cortisol serum concentration: IM, SUBQ: 3 to 12 hours.

Duration of action: Repository: 10 to 25 hours, up to 3 days.

Absorption: IM: Over 8 to 16 hours.

Half-life elimination: ACTH: 15 minutes.

Excretion: Urine.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Acthel | Acthelea;
  • (AT) Austria: Acth;
  • (CN) China: Adrenocorticotropin | Adrenocorticotropine | Corticotrophin;
  • (JP) Japan: Acth daiichi | Acthar;
  • (PE) Peru: Acth | Acthar;
  • (PH) Philippines: Acthar;
  • (SI) Slovenia: Acth
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